Philips Introduces 200-mm and 150-mm Stellarex 0.035-Inch Low-Dose DCBs

October 15, 2019—Royal Philips announced the United States introduction of two new balloons to its Stellarex 0.035-inch low-dose drug-coated balloon (DCB) portfolio. The new 200-mm and 150-mm Stellarex 0.035-inch low-dose DCBs have received FDA approval for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries.

The new balloons provide additional treatment options for patients with peripheral artery disease who have a high risk of restenosis. The Stellarex balloon is now available in lengths of 40, 60, 80, 100, 120, 150, and 200 mm for the treatment of lesions in the superficial femoral and popliteal arteries with vessel diameters of 4 to 6 mm.

According to Philips, the Stellarex portfolio has demonstrated a significant treatment effect and high safety profile. All Stellarex DCBs feature EnduraCoat technology, a coating consisting of a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles dispersed in it. The coating provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose.

On October 1, the company announced that results of third-party analyses of patient-level data from worldwide clinical trials of the Stellarex 0.035-inch low-dose DCB in lengths < 150 mm were published by William A. Gray, MD, et al in Circulation (2019;140:1145–1155).

Philips stated that the analyses provide extensive and rigorous safety assessments of its paclitaxel-based device. The primary safety analysis of the Stellarex DCB 3-year data, comprising a pooled set of large published randomized controlled trial data for a single paclitaxel-based device, showed no difference in mortality between patients treated with the Stellarex DCB versus those treated with percutaneous angioplasty.